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Ranolazine Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Ranolazine CAS No: 95635- 55- 5

Batch No: RAN/ 011114 A. R. No 14/ FP/ RAN/ 0111

Date of Manufacture Nov- 2014 Date of Analysis 02- 11- 14

Batch Quantity 100 kg Date of Retest Jan- 2017

Sr. No Test Results Acceptance Criteria

1. Appearance Complies White to off white crystalline powder

2. Identification Positive Positive

3. Loss on drying 0.32% NMT 1.0%

4. Residue on ignition Complies NMT 0.2%

5. Related substances 0.43%

NMT 1.0%

6. Heavy metals Complies NMT 20 PPM

7. Assay ( HPLC) 100.2%

NLT 98.5%

Ranolazine

Ranolazine. svg

Systematic ( IUPAC) name

( RS) - N- ( 2, 6- dimethylphenyl) - 2- [ 4- [ 2- hydroxy- 3- ( 2- methoxyphenoxy) - propyl] piperazin- 1- yl] acetamide

Clinical data

AHFS/ Drugs. com monograph

MedlinePlus a606015

Licence data EMA: Link, US FDA: link

Pregnancy

category

US: C ( Risk not ruled out)

Legal status

US: ℞ - only

Routes of

administration Oral

Pharmacokinetic data

Bioavailability 35 to 50%

Protein binding 62%

Metabolism Hepatic, CYP extensively involved

Biological half- life 7 hours

Excretion Renal ( 75% ) and fecal ( 25% )

Identifiers

CAS Registry Number 142387- 99- 3 Yes

ATC code C01EB18

PubChem CID: 56959

IUPHAR/ BPS 7291

DrugBank DB00243 Yes

ChemSpider 51354 Yes

UNII A6IEZ5M406 Yes

ChEBI CHEBI: 87681 Yes

ChEMBL CHEMBL1404 Yes

Chemical data

Formula C24H33N3O4

Molecular mass 427.537 g/ mol


Company Contact:


  • Phone: 912406641875

  • Address: PLOT NO: 04 JALGAON ROAD, HARSOOL, AURANGABAD, India

  • Email: Email


Published date: September 14, 2015 -

  • Business Description: We, at SWAPNROOP, are committed to providing affordable Drugs &

    Pharmaceuticals of global quality standards to Pharma Companies all over

    the world. In our warehouse facilities, approved by FDA. we supply

    Pharmaceutical Finished products, Dental products and Active

    Pharmaceutical Ingredients.

    We, at SWAPNROOP, are committed to providing affordable Drugs & Pharmaceuticals of global quality standards to Pharma Companies all over the world. Our warehouse facilities is approved by FDA and we are specializes in sales and marketing of Pharmaceutical Finished products, Pharmaceutical Active Ingredients (API's) and Dental products, providing a wide range of quality and affordable products to a large number of pharmaceutical companies, reputed private and government/semi government organizations/ research centers as well as universities.

    We supply and market over 500 molecules and their combinations in multiple dosage forms, catering to patient needs in various therapies. These include Anti infectives, Cardiovascular, Pain management, Central Nervous System (CNS), Gastrointestinal, Respiratory, Dermatology, Orthopaedics, Nutritionals, Urology and Dental.

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